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  • Dispositivo 1149
  • Fabricante 31827
  • Evento 1201
  • Implante 0
Device Recall SpermMar Test
  • Modelo / Serial
    Manufacturer's Product Number/Catalog Number: SPMA_S  Lot/Serial Number Expiration Date FP14A09 02/29/2016 FP14A10 04/30/2016 FP14A11 04/30/2016
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to the state of : OR., and Internationally to Argentina.
  • Descripción del producto
    SpermMar Test || 0.7ml Beads Particles || Label on bottle: || SpermMar Test IgA || 0.7ml Beads/Particles-50 Tests || IND REF SPMA_S || LOT Expiration || DO NOT FREEZE/NE PAS CONGELER || FertiPro N.V. || Label on box: || SpermMar || Test || IGA || 50 Determination || Test Kit || CONTENTS || 1 vial SpermMar Latex Particles 0.7 ml || REF SPMA_S || FertiPro || FertiPro N.V. || Label on box: || SpermMar || Test || IgA || 50 Determination Test Kit || Contents: 1 vial SpermMar latex particles, 0.7ml || FertiPro N.V. || For In Vitro Diagnostic || Use || SpermMar IqA Test || Manufacturer's Product Number/Catalog Number: SPMA_S || Lot/Serial Number Expiration Date || FP14A09 02/29/2016 || FP14A10 04/30/2016 || FP14A11 04/30/2016 || Product is a solution in filled into clear plastic bottles that is placed into a cardboard box. Both packages contain labeling information.
  • Manufacturer
    Vitrolife Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SpermMar Test
Device Recall Oxoid Legionella BCYE Growth Supplement SR0110A
  • Modelo / Serial
    Lot No. 1545171
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : MI, ND, SC, TN, and TX.
  • Descripción del producto
    Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstoke, Hants, England.
  • Manufacturer
    Remel Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Oxoid Legionella BCYE Growth Supplement SR0110A
Device Recall HardyCHROM SS Agar
  • Modelo / Serial
    Lot no. 15037, Expires: 00-00-2000
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- U.S., including the states of TX, CA, AZ, WA, PR, and IA; and the countries of Canada and NSW.
  • Descripción del producto
    Hardy Diagnostics cat no. G327 HardyCHROM SS Agar || (HardyCHROM Salmonella Shigella) || Cat no: G327 || Container type: 15x100mm monoplate || Packaged: 10 plates/sleeve || Storage: 2 to 8 degrees C. on receipt in dark || A selective chromogenic medium for the primary screening isolation, and differentiation of Salmonella & Shigella spp.
  • Manufacturer
    Hardy Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall HardyCHROM SS Agar
Device Recall Remel Blood Agar, 5 Sheep Blood REF R01202
  • Modelo / Serial
    Lot Number: 646595 and 646596 Expiration date: 19May2015
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack, 10/10-packs per case (100 plates). || Blood agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic reactions.
  • Manufacturer
    Remel Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Remel Blood Agar, 5 Sheep Blood REF R01202
Device Recall VersaTREK Automated Microbial Detection System
  • Modelo / Serial
    Serial numbers: 0169039201140624, 0169040501140626, 0169050101141007, 0169068601141216, 0169078101150213, 2163X1013, 2164X1013, 2165X1013, 2166X1013, 2167X1013, 2168X1013, 2169X1013, 2170X1013, 2171X1013, 2172X1013, 2173X1013, 2174X1013, 2175X1013, 2176X1013, 2177X1013, 2178X1013, 2179X1013, 2180X1013, 2181X1013, 2182X1013, 2183X1013, 2184X1013, 2185X1013, 2186X1013, 2187X1013, 2188X1013, 2189X1013, 2190X1013, 2191X1013, 2192X1113, 2193X1113, 2194X1113, 2195X1113, 2196X1113, 2199X1113, 2201X1113, 2202X1113, 2203X1113, 2204X1113, 2205X1113, 2206X1113, 2207X1113, 2208X1113, 2209X1113, 2210X1113, 2211X1113, 2212X1113, 2213X1113, 2214X1113, 2216X1113, 2217X1113, 2218X1213, 2219X1213, 2220X1213, 2221X1213, 2222X1213, 2223X1213, 2224X1213, 2225X1213, 2226X1213, 2227X1213, 2228X1213, 2229X1213, 2230X1213, 2231X1213, 2232X1213, 2233X1213, 2234X1213, 2235X1213, 2237X1213, 2238X1213, 2239X1213, 2240X1213, 2241X1213, 2242X1213, 2243X1213, 2245X1213, 2249X0114, 2250X0114, 2251X0114, 2252X0114, 2253X0114, 2254X0114, 2255X0114, 2256X0114, 2257X0114, 2261X0114, 2262X0114, 2263X0114, 2264X0114, 2268X0114, 2269X0114, 2276X0214, 2277X0214, 2278X0214, 2279X0214, 2280X0214, 2281X0214, 2282X0214, 2286X0214, 2287X0214, 2288X0214, 2289X0214, 2290X0214, 2306X0714, 2307X0714, 2309X0714, 2311X0714, 2312X0714, 2314X0714, 2315X0714, 2316X0714, 2317X0714, 2318X0714, 2320X0714, 2321X0814, 2322X0814, 2323X0814, 2330X0814, 2332X0814, 2333X0814, 2334X0814, 2336X0814, 2337X0814, 2338X0814, 2339X0814, 2340X0814, 2342X0814, 2345X0914, 2346X0914, 2347X0914, 2348X0914, 2349X0914, 2352X0914, 2353X0914, 2359X0914, 2365X0914, and 2366X0914;
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) to states of AZ, CO, FL, GA, IA, ID, LA, MI, MO, PR, TN, TX, VA, and WA and the countries of Canada, People's Republic of China, Egypt, Finland, France, Indonesia, Israel, Jordan, Kenya, Republic of Korea, Latvia, Romania, Russia, Spain, Thailand, United Kingdom, Uruguay, and Vietnam.
  • Descripción del producto
    VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. || The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
  • Manufacturer
    Remel Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VersaTREK Automated Microbial Detection System
Device Recall VersaTREK Automated Microbial Detection System
  • Modelo / Serial
    Serial numbers: 0169050501141020, 0169059801141031, 0169064701141210, 0169066801150105, 2200X1113, 2215X1113, 2236X1213, 2244X1213, 2272X0214, 2273X0214, 2274X0214, 2275X0214, 2298X0714, 2299X0714, 2300X0714, 2301X0714, 2303X0714, 2304X0714, 2326X0814, 2327X0814, and 2328X0814;
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) to states of AZ, CO, FL, GA, IA, ID, LA, MI, MO, PR, TN, TX, VA, and WA and the countries of Canada, People's Republic of China, Egypt, Finland, France, Indonesia, Israel, Jordan, Kenya, Republic of Korea, Latvia, Romania, Russia, Spain, Thailand, United Kingdom, Uruguay, and Vietnam.
  • Descripción del producto
    VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. || The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
  • Manufacturer
    Remel Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VersaTREK Automated Microbial Detection System
Device Recall PathoDx Strep Grouping Kit
  • Modelo / Serial
    lot 1470133, exp. date 31 Mar 2016
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution, including Puerto Rico and the country of Canada.
  • Descripción del producto
    PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. || Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or G from primary culture plates.
  • Manufacturer
    Remel Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PathoDx Strep Grouping Kit
Device Recall PathoDx Strep B Grouping Latex
  • Modelo / Serial
    lot 1463129, exp. date 31 May 2016
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution, including Puerto Rico and the country of Canada.
  • Descripción del producto
    PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. || Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.
  • Manufacturer
    Remel Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PathoDx Strep B Grouping Latex
Device Recall Granada Biphasic Broth
  • Modelo / Serial
    REF 42722 - Lot Numbers 896, 897 & 899
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA.
  • Descripción del producto
    Granada Biphasic Broth || The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Granada Biphasic Broth
Device Recall FB Broth
  • Modelo / Serial
    Cat. no. K31 Lot no.15231
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US. Distribution to the states of : CA, WI, MD and UT. .
  • Descripción del producto
    FB Broth, 10ml || (Fastidious Bacteria Broth) || Cat. no: K31 Lot: 15231 || A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens.
  • Manufacturer
    Hardy Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall FB Broth
Device Recall BacT/ALERT SN
  • Modelo / Serial
    Reference number: 259790, Lot number: 1042739, Expiry: 09JAN2016.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed in the countries of Angola, Austria, Bosnia, Bulgaria, Cameroon, Czech Republic, Democratic Republic of Congo, France, Germany, Greece, Hungary, Italy, Kazakhstan, Kingdom of Saudi Arabia, Kosovo, Lebanon, Netherlands, Niger, Pakistan, Poland, Republic of Belarus, Romania, Russia, Serbia, Sri Lanka, Spain, Sweden, Switzerland, United Arab Emirates, Turkey and Zimbabwe.
  • Descripción del producto
    BacT/ALERT¿ SN, bioM¿rieux, Inc. || Product Usage: || BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).
  • Manufacturer
    bioMerieux, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall BacT/ALERT SN
Device Recall BacT/ALERT FA
  • Modelo / Serial
    Reference number: 259791, Lot number: 1042923, Expiry: 25JAN2016 and Lot number 1042979, Expiry: 28JAN2016.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed in the countries of Angola, Austria, Bosnia, Bulgaria, Cameroon, Czech Republic, Democratic Republic of Congo, France, Germany, Greece, Hungary, Italy, Kazakhstan, Kingdom of Saudi Arabia, Kosovo, Lebanon, Netherlands, Niger, Pakistan, Poland, Republic of Belarus, Romania, Russia, Serbia, Sri Lanka, Spain, Sweden, Switzerland, United Arab Emirates, Turkey and Zimbabwe.
  • Descripción del producto
    BacT/ALERT¿ FA, bioM¿rieux, Inc., || Product Usage: || BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).
  • Manufacturer
    bioMerieux, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall BacT/ALERT FA
Device Recall API ZYM B (Ref 70493)
  • Modelo / Serial
    Lot No. PF - 1003765610/Lot No. Ampules - 1003693040/Exp. date 1/15/16 Lot No. PF - 1003772410/Lot No. Ampules - 1003711170/Exp. date 1/19/16 Lot No. PF - 1003772470/Lot No. Ampules - 1003733320/Exp. date 1/29/16 Lot No. PF - 1003787970/Lot No. Ampules - 1003693020/Exp. date 1/12/16 Lot No. PF - 1003790030/Lot No. Ampules - 1003790010/Exp. date 2/26/16 Lot No. PF - 1004077210/Lot No. Ampules - 1004024590/Exp. date 5/25/16 Lot No. PF - 1004097610/Lot No. Ampules - 1004040410/Exp. date 6/2/16 Lot No. PF - 1004355410/Lot No. Ampules - 1004306800/Exp. date 9/20/16 Lot No. PF - 1004355730/Lot No. Ampules - 1004306790/Exp. date 9/20/16
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution in the states of: AL, CA, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, ME, MD, MA, MI, MN, MS, MO, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TX, VT, VA, WA, WV, WI, WY
  • Descripción del producto
    API ZYM Bx2 (Ref 70493) || Product Usage: || ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips.
  • Manufacturer
    BioMerieux SA
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall API ZYM B (Ref 70493)
Device Recall Northeast Laboratory Services (NEL)
  • Modelo / Serial
    Al lot codes
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube || Catalog No.: T8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).
  • Manufacturer
    Northeast Laboratory Services, Inc.
  • 2 Events
    • Retiro De Equipo (Recall) de Device Recall Northeast Laboratory Services (NEL)
    • Retiro De Equipo (Recall) de Device Recall Northeast Laboratory Services (NEL)
Device Recall GBS Detect
  • Modelo / Serial
    Lot H16054 and H15056.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    U.S. Distribution to the following states: AL, SC, FL, CT, VA, WI, MA, MI, WV, OH, IN, IL, NC, and TX.
  • Descripción del producto
    Hardy Diagnostics GBS Detect || Cat no. A300. || Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
  • Manufacturer
    Hardy Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall GBS Detect
Device Recall TrypticaseTM Soy Agar with 5 Sheep Blood (TSA IITM) // MacConkey II Agar
  • Modelo / Serial
    Cat. Number Lot Number 221291 6034889
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, KS, LA, MA, MD, ME, MI, MN, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA.
  • Descripción del producto
    Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar || Cat. Number 221291, Lot Number 6034889, Exp. Date : April 20, 2016 || Product is sold in cartons of 100 plates each. || Product Usage: || Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and enteric pathogens.
  • Manufacturer
    Becton Dickinson & Co.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall TrypticaseTM Soy Agar with 5 Sheep Blood (TSA IITM) // MacConkey II Agar
Device Recall Sure Vue Color Staph IDSure Vue SELECT Staph IDbiokit Color Staph IDbiokit SELECT ...
  • Modelo / Serial
    Lot Numbers - KJ05016, KJ05017, KJ05018, KJ06019, KJ06020, KJ06021, KJ07023, KJ10028, J06022, KJ07024, KJ07025, KJ09026, KJ09027, KJ10029, KJ10030, KJ11034, KJ11035, KJ12040, KJ12041, KJ12042, KJ12043
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution to CA only.
  • Descripción del producto
    Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T || The product is used as an aid in the identification of Staphylococcus aureus from Culture
  • Manufacturer
    Integrated Science Systems Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Sure Vue Color Staph IDSure Vue SELECT Staph IDbiokit Color Staph IDbiokit SELECT Staph ID
Device Recall VITROS Immunodiagnostic HBsAg Controls
  • Modelo / Serial
    Product Code 6800598-Lot #'s: 1) 0860, 2) 0870, 3) 0880, 4) 0890, 5) 0908 Expiration: 1) 29-MAR-17, 2) 12-JUN-17, 3) 02-JUL-17, 4) 23-NOV-17, 5) 29-JAN-18
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
  • Descripción del producto
    VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 || For in vitro diagnostic use only. For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (heparin, EDTA or citrate). The performance of the VITROS Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assay.
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VITROS Immunodiagnostic HBsAg Controls
Device Recall Captia Measles IgM
  • Modelo / Serial
    Lot Number 2326060-043, Expiration Date 31 May 2017
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distribution to US nationwide including California, and China (Hong Kong).
  • Descripción del producto
    Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
  • Manufacturer
    Clark Laboratories, Inc. (dba,Trinity Biotech USA)
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Captia Measles IgM
Device Recall PREMIER EHEC and PREMIER EHEC Bulk
  • Modelo / Serial
    PREMIER EHEC Product Code 608096: Lot # 608096H219, Exp Date 9/7/2017, Detection Antibody Reagent, Lot # 8603.138 Exp Date 9/30/2017; Lot # 608096H222, Exp Date 12/20/2017, Detection Antibody Reagent, Lot # 8603.14 Exp Date 1/12/2018; Lot # 608096H224, Exp Date 9/7/2017, Detection Antibody Reagent, Lot # 8603.141 Exp Date 1/29/2018; Lot # 608096H225, Exp Date 12/20/2017, Detection Antibody Reagent, Lot # 8603.142, Exp Date 2/5/2018 & Lot # 608096H226, Exp Date 3/6/2018, Detection Antibody Reagent, Lot # 8603.143, Exp Date 3/22/2018.  PREMIER EHEC Bulk Product Code 608096BU: Lot # 608096H220 Exp Date 9/7/2017, Detection Antibody Reagent, Lot # 8603.138, Exp Date 9/30/2017; Lot #, 608096H223, Exp Date 12/20/2017, Detection Antibody Reagent, Lot # 8603.14, Exp Date 1/12/2018 & Lot # 608096H227, Exp Date 3/6/2018, Detection Antibody Reagent, Lot # 8603.143, Exp Date 3/22/2018.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Product was shipped to the following states: AL. AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WY. Product was also sent to the following countries: CANADA, GERMANY, HONG KONG, ITALY, JAPAN & NEW ZEALAND.
  • Descripción del producto
    PREMIER EHEC and PREMIER EHEC Bulk.
  • Manufacturer
    Meridian Bioscience Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PREMIER EHEC and PREMIER EHEC Bulk
Device Recall BD Affirm VPIII Microbial Identification Tests
  • Modelo / Serial
    Catalog Number Batch Number  446252 5126980  5135673  5138774  5140625  5142767  5153674  5153675  5224882  446257 5141655  5148857  5156873  5173648
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY and to the countries of : AU, BE, IN, KR, SG,
  • Descripción del producto
    BD AffirM VPIII Microbial Identification Test
  • Manufacturer
    Becton Dickinson & Co.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall BD Affirm VPIII Microbial Identification Tests
Device Recall Blood Agar (TSA with 5 Sheep Blood)
  • Modelo / Serial
    101686
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide distribution in the states of : AR, AZ, CO, IA, IL, KS, KY, LA, MI, MO, MS, MT, NC, ND, NE, NM, OH, OK, SD, and TX and Puerto Rico
  • Descripción del producto
    Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 || Product Usage: || Blood Agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic reactions.
  • Manufacturer
    Remel Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Blood Agar (TSA with 5 Sheep Blood)
Device Recall BBL Trypticase Soy Agar with 5 Sheep Blood (TSA II) and Chocolate II Agar (GC II A...
  • Modelo / Serial
    Part/Cat No. 221302  Lot / Serial No. 4365741
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of AR, CA, CO, FL, IL, NJ, NV, OR, PA, TX, and WA
  • Descripción del producto
    BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX)  I Plate || Product Usage: || Testing - Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. Chocolate II Agar is an enriched medium for the isolation and cultivation of Neisseria species.
  • Manufacturer
    Becton Dickinson & Co.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall BBL Trypticase Soy Agar with 5 Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglob
Device Recall Adenovirus (20/11 & 2/6)
  • Modelo / Serial
    0.5 mL - 1318203P , Expiry 2018-04; 7.0 mL - 1318204H 201, Expiry 8-04 11 and 1532111A, expiry 2018-10.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
  • Descripción del producto
    Adenovirus (20/11 & 2/6); || 0.5 mL Catalog # 212M-15; || and 7.0 mL Catalog number 212M-18 || Microbiology - Analyte Specific Reagent || In vitro diagnostic use - Analyte Specific Reagent
  • Manufacturer
    Cell Marque Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Adenovirus (20/11 & 2/6)
Device Recall H. pylori (polyclonal)
  • Modelo / Serial
    1.0 ml lot 1611307C, expiry 201 9-03.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
  • Descripción del producto
    H. pylori (polyclonal} || 1.0 mL Catalog number 215A-76; || Hematology - Analyte Specific Reagent || In vitro diagnostic use - Analyte Specific Reagent
  • Manufacturer
    Cell Marque Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall H. pylori (polyclonal)
  • 1
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Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

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